The Recall Desk
HighFDA (Devices)·Z-1575-2023·Announced 2023-05-17

STA R Max Analyzer Firmware Bug Produces Inaccurate Coagulation Test Results

Diagnostica Stago is recalling the STA R Max fully automatic clinical analyzer due to a firmware bug that causes intermittent shortened coagulation times and increased technical errors, potentially producing inaccurate blood clotting test results.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is a risk-of-harm medical device where the firmware defect produces inaccurate diagnostic test results. Although no illnesses or injuries have been reported, the potential for clinical harm through reliance on incorrect coagulation times warrants a High severity rating per the rubric.

Plain-English summary

Diagnostica Stago, Inc. is recalling the STA R Max fully automatic clinical instrument designed to perform tests on human plasmas due to a firmware bug identified during internal investigation.

The firmware defect causes intermittent shortened coagulation times and an increased frequency of a technical error (error 13) reported by the analyzer. These malfunctions can result in inaccurate test results that may not reflect the patient's actual blood clotting time, potentially affecting clinical decision-making.

Six analyzers are affected, with serial numbers CP86010393, DB68093186, CP87010814, CP86070669, CP86090743, and CP86090744. The devices are distributed nationwide in Illinois, Massachusetts, Minnesota, Nebraska, Texas, and Wisconsin.

Users of the affected analyzers should contact Diagnostica Stago, Inc. for firmware updates or replacement instructions. Healthcare facilities should verify the serial numbers of their instruments against the recall list and apply corrective measures provided by the manufacturer.

The recalled product

Product
STA R Max fully automatic clinical instrument designed to perform tests on human plasmas, Reference Numbers 59013 and 59026
Manufacturer
Diagnostica Stago, Inc.
Category
Medical Device — Clinical Laboratory Analyzer / Hematology
Hazard
  • firmware-bug
  • inaccurate-test-result
  • coagulation-analysis-error

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • UDI-DI: 036074505901

Distribution

Distributed nationwide across the United States.

Related recalls

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